US 20080103445 A1
An air bubble detection system includes an air bubble detector which is disposed downstream from a syringe or manifold used during an angiography procedure. The air bubble detection system monitors contrast medium being injected into the patient and creates an alarm or other indication if the air bubble exceeds any desired threshold.
1. A fluid injection system comprising:
an infusion path configured for injecting fluid into a patient;
at least one injection port configured for injecting a fluid into the infusion path;
an air bubble detector having a sensor disposed distally from the at least one injection port.
2. The fluid injection system of
3. The fluid injection system of
4. The fluid injection system of
5. The fluid injection system of
6. The fluid injection system of
7. The fluid injection system of
8. The fluid injection system of
9. The fluid injection system of
10. The fluid injection system of
11. The fluid injection system of
12. The fluid injection system of
13. The fluid injection system of
14. A fluid injection system comprising:
at least one syringe having contrast medium disposed therein;
at least one catheter disposed downstream of and in communication with the at least one syringe, so as to define a fluid flow path; and
an air bubble detector disposed along the fluid flow path downstream from the syringe
15. The fluid injection system of
16. The fluid injection system of
17. The fluid injection system of
18. The fluid injection system of
19. The fluid injection system of
20. A device for detecting air bubbles, the device comprising:
a housing comprising a conduit; and
an air bubble sensor attached to the housing for detecting an air bubble within the conduit.
21. The device according to
22. The device according to
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24. An air bubble detector comprising the device according to
25. The air bubble detector of
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27. An air bubble detector comprising the device according to
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42. A system for administering fluids comprising the device of
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45. A device for detecting air bubbles in a catheter, the device comprising:
an air bubble sensor; and
means for mounting the air bubble sensor on the catheter.
46. The device for detecting air bubbles of
47. The device for detecting air bubbles of
48. The device for detecting air bubbles of
49. The device for detecting air bubbles of
50. An air bubble detection system comprising the device according to
51. The device according to
52. A method for detecting air bubbles in system for injecting fluid into a human body, the method comprising;
selecting a system for injecting a fluid into a human body having a fluid flow path and at least one injection port for injecting fluid into the fluid flow path; and
disposing an air bubble sensor downstream from the at least one injection port.
53. The method according to
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55. The method according to
The present application claims the benefit of U.S. Provisional Application Ser. No. 60/827,622, filed Sep. 29, 2006, which is expressly incorporated herein in its entirety.
1. The Field of the Invention
The present invention relates to a method and apparatus for detecting air bubbles while injecting fluid into a patient. More specifically, the present invention relates to apparatuses and methods for detecting the introduction of air downstream from an injection port during use of a catheter in an invasive procedure, so as to minimize the risk of an air embolus being introduced into the bloodstream of a patient.
2. State of the Art
There are a variety of medical procedures in which a liquid is injected into a patient. In some situations, the introduction of air into the patient may be of little if any concern. In other procedures, however, the introduction of air can be of significant concern. One procedure in which the introduction of air can literally create a life or death scenario is angiography.
The use of angiography for a variety of medical procedures has become well known. In angiography a catheter is advanced into the circulatory system of an individual. A contrast medium is then injected into the individual through the catheter. The contrast medium is observed using a fluoroscope so as to allow physicians to better view structures inside the body. Angiography can be used simply to assist the physician with advancement of the catheter, with the imaging being used to help the physician navigate through the arteries, etc. It may also be used in procedures such as the placement of a stent in a venous system so as to prevent occlusion or collapse of a blood vessel to ensure that the stent is placed at the proper location to prevent closing of the vessel. Likewise angiography can be used to take pictures of heart valves or other structures as they function in order to determine the proper treatment for circulatory problems. Angiography also can be used to determine the location of a blood clot in the brain so that ameliorative therapies may be focused on the particular point of concern.
An angiography can be a complex procedure. Typically a surgeon will utilize one or more syringes to inject the contrast medium through the catheter. Thus, as shown in
While the configuration shown in
During the procedure the physician will typically be watching a fluoroscope or other monitor to view the interior structures of the body made visible by the contrast medium. While he or she does so, the physician may be manipulating one or more plungers to inject a desired amount of contrast medium to aid in that visualization. Because a physician must carefully watch the monitor, the physician will typically not be looking at the syringes as they are used to inject fluid through the catheter.
The catheter 14 will typically be inserted into the femoral artery and advanced toward the heart. As the physician advances the catheter, the location of the distal end 14 a can be monitored by injecting small amounts of contrast medium and watching the monitor 48 of the fluoroscope. Once the distal end 14 a of the catheter 14 is in the desired position, the syringes 28 can be used to inject larger amounts of contrast medium, or the pump 36 can be used to inject a large amount of contrast medium in a very short amount of time.
One concern when conducting an angiography is the introduction of air into the circulatory system of the patient. Because angiography often takes place near the heart and/or the brain, the introduction of air can run a substantial risk of creating an embolism and causing serious injury to the patient. Thus, it is important that the contrast medium injecting system be free from any substantial quantity of air. In some procedures, the amount of air should not exceed 50 μl (microliters).
To accomplish this goal, the surgical staff will typically fill each of the syringes with contrast medium and attempt to remove any air pockets. The syringes are then typically attached to a manifold which connects to the catheter, and the manifold and catheter are primed to remove excess air.
While surgical staff is usually diligent in removing the air, there remains a risk for the patient. If the syringes, manifold, and catheter, have not been carefully primed and tightly sealed, there remains a risk that air can remain in the contrast medium flow path or be drawn in through the attachments between the syringes and manifold and/or manifold and catheter. Additionally, if pressure is applied to the syringes, the syringe may contain a larger quantity of air that has been compressed by the pressure, thus leading to the false assumption that only a small bubble of air is present.
In recent years some have appreciated the concern of large quantities of air being introduced into a patient and have placed air bubble detectors adjacent to the contrast medium pump 36 (
It is an object of the present invention to provide an apparatus and method for reducing the risk of air or other gas bubbles being introduced into a patient.
In accordance with one aspect of the invention, an air bubble detector is disposed distally (i.e. downstream or toward the patient) of the point(s) of fluid injection, through which fluid is injected into a patient.
In accordance with one aspect of the invention the air bubble detector is disposed so that at least the air bubble sensor is disposed downstream from the syringe in order to detect any air that may be introduced into the catheter by actuation of the syringe.
In accordance with another aspect of the present invention, the air bubble detector is disposed downstream from the manifold which receives an injected fluid from a plurality of syringes so as to detect a predetermined amount of air passing from the manifold into the catheter regardless of whether the air enters the manifold from the syringes, from connections of the syringes to the manifold, or from a position upstream from the manifold.
In accordance with another aspect of the invention, the air bubble detector may be configured such that part of the air bubble detector is disposed within the sterile field and a portion of the bubble detector may be disposed outside of the sterile field so as to minimize the portions of the bubble detector that must be either sterilized or disposed of following a procedure.
In accordance with another aspect of the present invention, the air bubble detector is configured for attachment between the manifold and the catheter so as to form part of the flow path of the contrast medium injection system.
In accordance with another aspect of the invention, the air bubble detector may be configured for placement on the catheter so as to detect the presence of air bubbles within the catheter.
These and other aspects of the present invention are realized in an air bubble detector and in an injection system as shown and described in the following figures and related description.
Various embodiments of the present invention are shown and described in reference to the numbered drawings wherein:
It will be appreciated that the drawings are illustrative and not limiting of the scope of the invention which is defined by the appended claims. It is further appreciated that not all aspects or structures of the invention may be shown in a single drawing, and as such various drawings illustrate smaller parts of the invention shown in other drawings. The various embodiments shown accomplish various aspects and objects of the invention, and it is not necessary that any particular embodiment accomplish all aspects and objects of the invention.
The drawings will now be discussed in reference to the numerals provided therein so as to enable one skilled in the art to practice the present invention. The drawings and descriptions are exemplary of various aspects of the invention and are not intended to narrow the scope of the appended claims. It is appreciated that not all structures and elements of the invention may be shown in a single drawing and multiple drawings are therefore presented, each drawing more clearly illustrating all or a portion of the invention, and various parts of the drawings may be combined with parts of other drawings. Furthermore, it will be appreciated that various portions of the invention will be discussed with respect to various figures and may not be repeated with respect to each figure to provide a clear and concise disclosure of the invention. Additionally, it will be appreciated that not all embodiments or ports of embodiments need meet each object of the invention and such should not be viewed as limiting the appended claims.
Turning now to
The fluid injection system, generally indicated at 100, includes an infusion line 104 for carrying contrast medium from a contrast medium pump 108 to the manifold 112. A plurality of syringes 116 are attached to a plurality of fluid injection ports 120 on the manifold 112. Each of the syringes 116 and each of the fluid injection ports 120 raises a risk that air will be injected or drawn into the fluid infusion path as it extends to the catheter 124. (While the catheter is shown herein as being a straight member, it will be appreciated that the catheters are usually flexible to accommodate the tortuous structure of the circulatory system.)
In accordance with the present invention, an air bubble detector 130 is disposed at least partially downstream from the contrast medium injection ports 120 on the manifold. As will be explained in additional detail below, this allows for the detection of air (or other gas—collectively referred to herein as air) bubbles regardless of whether they have been introduced from the pump 108, the syringes 116, the fluid injection ports 120 or the attachment points of the manifold 112.
The air bubble detector 130 may include several parts. First, the air bubble detector 130 typically includes a sensor 134. A variety of different sensors may be used. Two commonly used types of sensors for bubble detection are ultrasonic sensors and optical sensors. Ultrasonic sensors typically use a piezoelectric material, such as a crystal, PVDF or ceramic material to generate high frequency sound (ultrasound). The sound waves travel through the conduit which is being monitored for air bubbles. If the conduit is filled with liquid, the ultrasonic signals are received by a piezoelectric material on the opposite side. The piezoelectric material creates an electrical signal in response to the sound waves, thereby indicating that liquid is present in the tube.
One ultrasonic bubble detector sold by ZEVEX, Inc. of Salt Lake City, Utah is particularly advantageous, as the frequency of the electrical signal driving the piezoelectric material is swept. Sweeping the frequency provides a more reliable result and reduces false positives created by mismatched transmitter/receiver pairs, environmental conditions, etc. This is due to the fact that the combined resonance of the sensor, the sensor housing, tubing, fluid, etc., can vary due to size differences, material differences, temperature and other environmental conditions. Thus, the combined or system resonance can change for a variety of reasons which cannot be readily controlled either during production of the sensor or during use by the physician. By using the circuitry to sweep the frequency, changes in the size of the manifold or housing, the conduit, the temperature, etc., can be adapted to without requiring input or adjustment by the user.
Air bubble detectors can also take other forms. For example, an optical emitter can direct light into a conduit configured for carrying fluids. If air is present, the light may be directed to a receiver, while the presence of an opaque liquid will substantially prevent the transmission of light. If clear liquids are used, the presence of air will cause a different index of refraction to be present at the chamber/fluid interface than if a clear liquid is present. A more detailed explanation of optical bubble detectors is set forth in U.S. Pat. No. 6,531,708, which is expressly incorporated herein. Those skilled in the art will appreciate that there are numerous different methods for determining the presence of air which could be used. For brevity, the sensor will be discussed in the context of an ultrasonic sensor. (It will be appreciated, however, that the claims should not be limited to such unless specifically limited therein).
The air bubble detector 130 may also include a signal processing unit 138 disposed in communication with the sensor 134. The signal processing unit 138 receives input from the sensor 134 to generate signals determinative of whether a bubble is present. The signal processing unit 138 can use buffers or other means for reducing noise in the signals.
The air bubble detector 130 will also typically include an indication or alarm mechanism 142 for providing an indication that an air bubble is present in the contrast medium infusion path. The indication mechanism may include a display panel for indicating status. It may also include a mechanism for producing a human perceptible alarm, such as a light which can be made to flash, and/or a speaker for emitting an alarm signal when a bubble has been detected.
The air bubble detector 130 can also include a communication module 146. The communication module 146 can be used for communications within the air bubble detector, or which other structures such as a contrast medium pump 108 or a fluoroscope monitor 150. The communications module 146 may be wired, or may rely on wireless technologies including, but not limited to, radio frequency, BLUETOOTH, and other wireless protocols.
The air bubble detector 130 may also include an injection control mechanism 154. The injection control mechanism 154 may be disposed in communication with the contrast medium pump 108 to automatically stop injection if an air bubble of sufficient size is detected. It will be appreciated that, especially under high pressure injection, the air bubble detector 130 could stop the pump 108 much more quickly than the physician's reflexes. In the alternative, the injection control mechanism 154 could temporarily suspend injection of contrast medium subject to an override by the physician.
While the various potential components of the air bubble detector 130 are discussed and shown as separate structures in
Those skilled in the art will appreciate that such a system provides a significant improvement in safety. In the event that the syringes 116, the manifold 112 and the catheter 124 have not been checked and primed properly, the air bubble detector 130 will allow the physician to detect and prevent an air bubble from passing through the catheter and into the patient.
One challenge which is present in the context of an angiography, is use of the air bubble detector 130 within the sterile field, indicated by curved line 156. Because ultrasonic air bubble detectors can be relatively expensive, provision can be made to either facilitate reuse of at least part of the air bubble detector, or to keep the expense of the air bubble detector to a minimum when practical. As is discussed in detail below, there are several methods by which this can be accomplished.
Turning now to
Turning now to
The manifold 170 also includes a plurality of injection ports 120 for injecting contrast medium into the contrast medium path, conduit 182, which is formed in part by the manifold. Typically, the injection ports 120 include luer lock connectors 186 for receiving and holding syringes filled with contrast medium.
The manifold 170 may also include a recess 190 configured to receive at least part of an air bubble detector. For example, the recess 190 may be formed to receive the sensor 134 discussed with respect to
The air bubble detector 204 preferably has a first connector 208 for attachment to the manifold 112, or to an intervening structure. Those of skill in the art will appreciate that pressure transducers can be attached to the manifold for ensuring that the contrast medium does not exceed certain pressure thresholds. The air bubble detector 204 also includes a second connector 212 for attachment to the catheter, etc. Thus the air bubble detector 204 is placed along the flow path of the contrast medium and is able to detect air bubbles from any source upstream. Typically, the connectors 208 and 212 will be luer lock connectors. However, other connectors could be used. The air bubble detector 204 may communicate wirelessly or may incorporate an alarm, etc.
The house 220 holds a sensor 234 formed by a transmitter 234 a and a receiver 234 b. As was discussed previously, it will be appreciated that the transmitter 234 a and receiver 234 b may transmit and receive sound or light or other signals for determining the presence of air. For simplicity, the sensors will be discussed in the context of an ultrasonic sensor.
Power is supplied to the sensor 234 by a power source 238, such as a battery. The ultrasonic transmitter 234 a sends acoustic waves through the conduit 242. The ultrasonic receiver 234 b generates a signal in response to the acoustic waves detected. The signal may then be processed by a signal processor 246. The sensor results are then sent via a transmitter 250 to a remote monitor 254. The transmitter 250 may operate on radio frequency, via BLUETOOTH, or other wireless protocols.
Once the monitor 254 has received the information from the transmitter 250, the monitor will provide some indication whether there is an air bubble in the contrast medium. This can be done via a visual display 260, via a flashing light 264 and/or via an audible alarm 268. Input means 266, such as buttons, keys or dials, may be used to adjust the sensitivity of the sensor and/or alarms.
One advantage of the visual display 260 is that it could keep a cumulative count of bubbles detected. Thus, for example, the sensor 234 may not have detected a single air bubble which would cause concern. However, if it detected a number of small air bubbles, the monitor could display an approximate volume of air which had been injected. The physician could then determine if the risk of an air embolus was too great to proceed. Additionally, the monitor 254 could be disposed in communication with the pump 108 (
While less sophisticated than the embodiments discussed in
Turning now to
A pair of wires 312 extend from the sensor 304. The wires 312 carry activation signals to the sensor 304, such as by wire 312 a, and carry signals generated by the sensor back to a monitor 316. It will be appreciated that the monitor 316 may have all of the features and components discussed with respect to monitor 254 shown in
To facilitate either a disposable sensor 304 or a resterilzeable sensor, all of the processing circuitry, power and means for developing an alarm signal or other indication means can be disposed in the monitor 316. Thus, the monitor can be reused, while the sensor 304 can be discarded.
The configuration shown in
Turning now to
While the air bubble detectors described herein may be used in the more complex systems using a manifold, they may only be used in more simple procedures requiring only a single syringe. Thus,
It will be appreciated in light of the present invention that at least a portion of the air bubble detector may be integrated into a manifold to reduce set-up time and decrease the number of connections through which a leak could occur. Thus,
The manifold also has an air bubble sensor 434 attached to or disposed in the housing 404. The air bubble sensor 434 may include a pair of piezoelectric elements, a single element, an optical bubble detector which interacts with a portion of the conduit 406 or other types of air bubble sensors. By integrating the manifold and the air bubble sensor less attachments are used, thus reducing the potential number of leaks.
The manifold 400 may carry only the air bubble sensor 434 or may include an entire air bubble detector, generally indicated at 440. Thus, the housing 404 may enclose or have attached thereto, processing circuitry 444, a battery 446 for powering the sensor 434, etc., The housing 404 may also enclose or have attached thereto alarm or indication means for generating a human perceivable signal, such as a light 448 and/or a speaker 450. A control switch 454 for turning the sensor 434 on or off, adjusting sensitivity of the sensor 434 and/or the volume of the alarm may also be used. A visual display 458 may also be provided. It will be appreciated that if the desire is to keep costs to a minimum, the manifold 400 may only include the air bubble sensor 434 and wiring 460 for connection to a remote monitor, etc., which would have the processing circuitry, power supply, etc.
Additionally, the manifold 400 may also include one or more other sensors, such as a pressure sensor, a flow rate sensor, or a cumulative dosage sensor, shown collectively at 470 and 474. Those skilled in the art will appreciate that such sensors can be implemented in a number of different ways. Additionally, the sensors 470, 474 may share the control circuitry 444 and battery 446, or may utilize wiring 460 to communicate with remote processors, etc.
The combined sensor 500 also includes a port 520 which provides access to the fluid for a pressure sensor 524 to determine the pressure of the fluid in the conduit 508. Disposed along the conduit 508 is also an air bubble sensor 534 for detecting the presence of air bubbles. The pressure sensor 524 and/or the air bubble sensor 534 may be powered by a battery 540 or other power source in the housing, or may be powered by wiring 544 which extends to an external monitor. Likewise, signal processing and the generation of alarms can be performed by sending signals to remote monitors, etc. via the wiring 554. In the alternative, a power supply 540, circuitry 550, and monitoring devices and alarms 554 such as those discussed with respect to
The combined sensor 500 shown in
Those skilled in the art will appreciate numerous different ways for forming the various sensors. For example, a flow rate sensor could be formed by measuring the pressure change on the fluid as it passes through a constriction. Flow rate monitoring could also be determined more invasively, such as a sensor which extends into the fluid passing through the conduit. Cumulative dosage can be determined by knowing the volume, the flow rate and the time for which the fluid has been flowing.
Thus there is disclosed an improved method and apparatus for detecting air during an angiography or other medical procedure. Those skilled in the art will appreciate that numerous modifications could be made to the various embodiments disclosed herein without departing from the scope and spirit of the invention. The appended claims are intended to cover such modifications.